Apremilast from Celgene being trialled for rosacea

Written by on January 12, 2010 in clinical trials with 5 Comments

The first time you hear of a new drug, you probably ask – what is it ? Well are you ready for a marketing mouthful – “Apremilast is a novel, orally available small molecule compound that exhibits anti-inflammatory activities through the suppression of multiple pro-inflammatory mediators including, TNF-alpha, interleukins 6, 17 & 23, and interferon-gamma among others.”

Apremilast (CC-10004) has been trialled for use in psoriasis and psoriatic arthritis. It would seem that Celgene are now interested in seeing if Apremilast is useful for treating another inflammatory skin condition such as rosacea.

Open Label Pilot Study of Apremilast in Treatment of Rosacea

An Open Label, Pilot Study to Determine the Efficacy of Apremilast in the Treatment of Rosacea in Patients With Both Erythematotelangiectatic Rosacea and Papulopustular Rosacea

This is a single-center, open label trial of Apremilast in ten (10) subjects with moderate to severe inflammatory rosacea who will be treated with Apremilast 20 mg twice per day for 12 weeks. Following the screening period and baseline visit, study subjects will return at weeks 1, 2, 4, 6, 8, 10 and 12. There is a follow up study visit at week 16.

Recent research has shown an increase of specific proinflammatory cytokines in the biopsies of inflammatory lesions from rosacea and acne patients. The cytokines then trigger a chain of chemical responses in the body that likely result in the development of the papules an pustules that are seen in rosacea and acne patients. Apremilast is an oral agent that modulates multiple anti-inflammatory pathways and has pharmacodynamic properties with potential therapeutic benefit for treating inflammatory autoimmune disorders.

We therefore propose a pilot study to evaluate the potential for Apremilast to improve the signs and symptoms of moderate to severe inflammatory rosacea.

Note that the list of inclusion and exclusion is long and slightly scary looking. Celgene are obviously quite concerned about unintended side effects of their new drugs.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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5 Reader Comments

  1. Doug says:

    Any updates on this trial?

  2. Doug says:


  3. Jasmine 215 says:

    I would like to know about the latest findings about this trial, too. Since not too many oral medications like antibiotics will work for me any more.

  4. Hi Jasmine,

    Have you asked your doctor about the possibility of the macrolide antibiotics to treat your rosacea ?

    I would think it will be several years before any of this research results in a product.


  5. fatih metin says:

    ben bu ilacı faz 4 olarak kullandın Konya da ikamet etmekteyim ve halen Konya da meram tıp fakültesinde çalışma devam ediyor

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